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medtronic model 5062
Medtronic Vascular
Summary: The Medtronic Model 5062 is an IVC filter designed to prevent pulmonary embolism. It is FDA-cleared and supported by clinical studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K853398 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Medtronic Model 5062 was cleared through the FDA 510(k) pathway on December 4, 1985. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 5062 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients who are at risk of developing embolic events.
Clinical Applications
This device is commonly used in patients with contraindications to anticoagulation therapy or those who have experienced recurrent embolic events despite anticoagulation. It is placed in the inferior vena cava to intercept thrombi.
Evidence Summary
The available literature includes five studies, with a mix of study designs such as RCTs and retrospective analyses, spanning from 2023 to 2026. These studies provide insights into device efficacy and safety.
Reported Outcomes
Published studies report limited specific outcomes related to the Medtronic Model 5062. The evidence primarily focuses on the device's role in preventing pulmonary embolism, though detailed efficacy data is sparse.
Safety Profile
Reported complications include general risks associated with IVC filters, such as filter migration and perforation. However, specific safety data from the provided studies is not detailed.
Evidence Limitations
The evidence base for the Medtronic Model 5062 is limited, with few studies directly addressing its efficacy and safety. Further research is needed to establish comprehensive outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Medtronic Model 5062?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes are limited, but the device is generally used to prevent pulmonary embolism.
What complications have been reported?
Safety data is limited, but potential complications include filter migration and perforation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.